Phase 3 Tuberculosis Trial, Recruiting NCT04145258 Sponsor: ANRS, Emerging Infectious Diseases Condition: Tuberculosis
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Phase 3 Tuberculosis Trial, Recruiting

NCT04145258
Recruiting Phase 3

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People aged 15 years or older
  • People who have been diagnosed with tuberculous meningitis (a serious brain infection caused by tuberculosis), confirmed or suspected based on specific medical test results or scoring systems (confirm with trial site)
  • People who have provided signed informed consent to participate

Who may not be able to join:

  • People who have already received more than 5 days of tuberculosis treatment
  • People with severe kidney disease, where the kidneys are working at a very low level
  • People with a very low white blood cell count (a type of cell that fights infection)
  • People with a low red blood cell count or low haemoglobin (a sign of significant anaemia)
  • People with significantly elevated bilirubin levels in the blood, which can indicate liver or blood problems
  • People with a very low platelet count (platelets help blood to clot)
  • People with significantly elevated liver enzyme levels (a sign the liver may be under stress)
  • People with signs of serious liver disease or liver failure
  • Women who are more than 17 weeks pregnant, or who are breastfeeding
  • People who are fully conscious and alert but who have significant nerve damage affecting their limbs, rated at a certain severity level (confirm with trial site)
  • People whose tuberculosis bacteria have been shown to be resistant to the antibiotic rifampicin
  • People whose spinal fluid test results suggest a different type of infection (such as bacterial or fungal meningitis)
  • People with signs of active bleeding anywhere in the body, such as coughing up blood, bleeding in the gut, blood in the urine, or bleeding in the brain
  • People from whom a spinal fluid sample cannot be collected, unless tuberculosis has already been confirmed through another type of test and there is other evidence of meningitis
  • People who have had major surgery within the two weeks before joining the trial
  • People who are currently taking aspirin on an ongoing basis (for example, for heart health)
  • People currently taking certain other medications that cannot be safely stopped and that are known to interact with the trial drugs
  • People with a known history of bleeding in the brain, stomach ulcers, gut bleeding within the past 3 months, a known allergy to the trial drugs, a condition called porphyria, or a condition involving high uric acid levels or gout
  • People where the trial doctor has concerns that participation would not be safe or practical for that individual

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 21 July 2026
Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Fabrice Bonnet, M.D., Ph.D., University Hospital, Bordeaux

Phone: +33 (0)5 56 79 58 26

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 3
Sponsor
ANRS, Emerging Infectious Diseases
Registry
ClinicalTrials.gov
Start date
7 February 2021
Est. completion
23 September 2026

Where this trial is recruiting

Côte d’Ivoire Madagascar 🇿🇦 South Africa Uganda

Primary endpoints

Rate of all-cause death

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 21 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov